Regulatory Specialist-Scientific Writer

Regulatory Specialist-Scientific Writer#26-10834 Newark, DE All On-site Job Description Regulatory Specialist-Scientific Writer This is a Scientific Writer contractor position supporting Global Regulatory Science Operations at the Haskell Research Station. The Scientific Writer will be responsible for drafting and finalizing toxicology protocols, study reports, and study summaries to support regulatory submissions for crop protection products. The role requires strong scientific writing skills, a solid understanding of Good Laboratory Practice (GLP), and the ability to collaborate effectively with cross functional stakeholders.

Start:

ASAP after interviews

• Weekly Schedule (how many hours/days): 40 hours

Shift Times:

8am-5pm

• Interview Required? Yes, 1 round and could be In-person and/or Teams interview with team members and stakeholders.
• Resume Required? Yes
• Any specific skills, requirements or experience you want in a candidate: BS in biology, microbiology, or a related scientific discipline.

Prior experience with scientific writing and GLP experience preferred. Ability to manage multiple projects simultaneously and meet tight deadlines. Strong attention to detail. Experience using Adobe Acrobat Pro to compile and edit documents is preferred. Proficient in using Microsoft Office Suite and document management systems.

• Any additional Medical Surveillance testing required? No
• Any exposure to common allergens? No
• Will non-local/remote candidates be considered? No
• Reason for Opening position? Backfill Job Summary
• Draft high-quality toxicology protocols, study reports and study summaries to support Crop Protection regulatory submissions.
• Strong scientific writing skills and a background in mammalian toxicology, ecotoxicology, or related biological science are needed for drafting reports.
• Perform quality control (QC) reviews on draft reports. An understanding of Good Laboratory Practice (GLP) is required.
• Contribute to the development and revision of report templates and assist with process optimization efforts.
• Facilitate finalization of reports and audit responses.
• Communicate effectively with key stakeholders and customers.
• Partner with stakeholders and customers to understand regulatory reporting requirements. Job Requirements
• Bachelor's degree or higher in biology, microbiology, or a related scientific discipline.
• Demonstrated experience in scientific writing, preferably within the regulatory or crop protection industry.
• Strong understanding of Good Laboratory Practice (GLP) standards and regulatory guidelines.
• Excellent attention to detail and ability to perform quality control reviews on scientific documents.
• Proficient in using Microsoft Office Suite and document management systems.
• Effective communication and collaboration skills with cross-functional teams and stakeholders.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Experience using Adobe Acrobat Pro to compile and edit documents is preferred.